Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Dose escalation phase only: People with a confirmed advanced or spreading cancer that cannot be surgically removed, and for which standard treatments no longer exist or are no longer working.
• Dose expansion phase only: People with a confirmed invasive breast cancer that is either locally advanced (spread to nearby tissue) or metastatic (spread to other parts of the body).
• People aged 18 or older (children are not eligible because safety data in that age group is not yet available for these study drugs).
• People who are well enough to carry out some daily activities — specifically, those with an ECOG performance score of 2 or lower (a measure doctors use to assess general wellbeing and ability to do daily tasks).
• People whose blood test results meet certain thresholds, including healthy enough levels of infection-fighting white blood cells, platelets, liver enzymes, kidney function, and blood clotting markers (confirm specific values with the trial site).
• People who have received at least one prior round of chemotherapy, and who have not previously had a type of chemotherapy called an anthracycline stop working while treating metastatic disease (anthracycline given before or after surgery is allowed, provided the cancer did not return within 6 months of finishing it).
• People who have previously received a type of treatment called a PARP inhibitor — this is allowed.
• No specific inherited gene mutation is required to join.
• Dose escalation phase only: People whose cancer tests show one of the following: HER2-positive (IHC 3+) solid cancer; HR+ HER2-positive, HER2-low, or HER2-ultralow breast cancer, or triple-negative breast cancer (TNBC) that is HER2-low (confirm HER2 definitions with the trial site).
• Dose expansion phase only: People whose breast cancer (in the original tumour or a metastasis) is classified as HER2-low or HR+ HER2-ultralow, with hormone receptor status known (confirm exact HER2 definitions with trial site).
• People who have at least one tumour that can be measured on scans and is located outside of any previously treated radiation area.
• People with mild or no nerve damage in the hands or feet (grade 1 or lower peripheral neuropathy).
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%, confirmed by a heart scan within 28 days before joining.
• People living with HIV who are on effective treatment and have had an undetectable level of virus in the blood within the past 6 months.
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment.
• People who have had hepatitis C and been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
• People who have had brain metastases that were treated, provided follow-up brain scans show no sign of the cancer growing back.
• People with new or growing brain metastases or spread to the lining of the brain, if the treating doctor determines that immediate brain-specific treatment is not needed during the first treatment cycle.
• People with a history of heart disease or prior treatment with heart-affecting drugs, provided a doctor assesses their heart function as Class II or better using a standard heart function scale.
• People who have or have had another cancer, if that cancer or its treatment is unlikely to interfere with the safety or results of this trial.
• People who are willing and able to use effective contraception (hormonal, barrier, or abstinence) starting 14 days before joining and throughout the trial — for women who could become pregnant, this must continue for at least 7 months after the last dose; for men, for at least 6 months after the last dose.
• Women who cannot become pregnant due to surgical sterilisation or confirmed menopause are also eligible. Women on hormone replacement therapy whose menopausal status is uncertain may need to pause hormone replacement therapy or use contraception (confirm with trial site).
• Male participants must agree not to freeze or donate sperm from the start of screening until at least 6 months after the final dose (sperm preservation before joining is recommended).
• Female participants must agree not to donate or retrieve eggs from the start of screening until at least 7 months after the final dose.
• People who are willing and able to give written informed consent (a legal representative may do so on their behalf if needed).
• People who have had chest radiation therapy — note: those who received it within the past 4 weeks (or 2 weeks for a specific short-course type) are excluded, not included (see exclusion list below).

Who may not be able to join:

• People who have had, or currently have, a non-infectious lung condition called interstitial lung disease (ILD) that required steroid treatment, or where a similar lung condition cannot be ruled out by scans at the start of the study.
• People with serious lung problems caused by other illnesses, including blood clots in the lungs within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restricted lung capacity, fluid around the lungs, or autoimmune or inflammatory conditions that can affect the lungs (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis), or people who have had a lung surgically removed.
• People who have received chemotherapy, antibody-drug therapy, retinoid therapy, or hormonal cancer therapy within the past 3 weeks (or longer for certain drug types — confirm timeframes with the trial site).
• People who have received cancer immunotherapy or monoclonal antibody therapy within the past 4 weeks.
• People who have had major surgery within the past 4 weeks.
• People who still have unresolved side effects from previous cancer treatments (other than hair loss) that have not returned to a mild or baseline level.
• People currently taking certain medications known to strongly interact with a liver enzyme called CYP3A4 — these are known as strong CYP3A4 inhibitors or inducers (confirm the specific medications with the trial site).
• People currently participating in another clinical trial involving an investigational treatment.
• People with a known history of serious allergic reactions to drugs similar to the study medications, or to other monoclonal antibodies.
• People with a heart electrical abnormality called a prolonged QTc interval, above specific thresholds on an ECG (electrocardiogram) at screening (confirm thresholds with trial site).
• People with significant eye surface disease or certain eye conditions, as assessed by the study doctor.
• People with other serious uncontrolled illnesses or conditions that the trial team considers would make participation unsafe.
• People who are pregnant.
• People who are breastfeeding (breastfeeding must also be avoided for 7 months after the last dose).
• People who have had chest radiation therapy within the past 4 weeks (or within 2 weeks for a short-course palliative type).

Important: Always verify eligibility with the trial site directly before applying.